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Relevant bibliographies by topics / FOOD AND DRUGS ADMINISTRATION

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Academic literature on the topic 'FOOD AND DRUGS ADMINISTRATION'

Author: Grafiati

Published: 11 September 2023

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Journal articles on the topic "FOOD AND DRUGS ADMINISTRATION"

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Hutcheon, Duncan E. "Drugs Approved by Food & Drug Administration." Journal of Clinical Pharmacology 29, no. 5 (May 1989): 478–79. http://dx.doi.org/10.1002/j.1552-4604.1989.tb03366.x.

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Furlan, Anthony J., and Marc Fisher. "Devices, Drugs, and the Food and Drug Administration." Stroke 36, no. 2 (February 2005): 398–99. http://dx.doi.org/10.1161/01.str.0000153057.07181.94.

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Tsimberidou, Apostolia-Maria, Fadi Braiteh, David J. Stewart, and Razelle Kurzrock. "Ultimate Fate of Oncology Drugs Approved by the US Food and Drug Administration Without a Randomized Trial." Journal of Clinical Oncology 27, no. 36 (December 20, 2009): 6243–50. http://dx.doi.org/10.1200/jco.2009.23.6018.

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Purpose To approve a new anticancer drug, the US Food and Drug Administration often requires randomized trials. However, several oncology drugs have been approved on the basis of objective end points without a randomized trial. We reviewed the long-term safety and efficacy of such agents. Methods We searched the Web site of the US Food and Drug Administration's Center for Drug Evaluation and Research and MEDLINE for initial applications of investigational anticancer drugs from 1973 through 2006. Results Overall, 68 oncology drugs, excluding hormone therapy and supportive care, were approved, including 31 without a randomized trial. For these 31 drugs, a median of two clinical trials (range, one to seven) and 79 patients (range, 40 to 413) were used per approval. Objective response was the most common end point used for approval; median response rate was 33% (range, 11% to 90%). Thirty drugs are still fully approved. United States marketing authorization for one drug, gefitinib (an epidermal growth factor receptor [EGFR] inhibitor), was rescinded after a randomized trial showed no survival improvement; however, this trial was performed in unselected patients, and it was subsequently demonstrated that patients with EGFR mutation are more likely to respond. Nineteen of the 31 drugs have additional uses (per National Comprehensive Cancer Network or National Cancer Institute Physician Data Query guidelines), and subsequent formal US Food and Drug Administration approvals were obtained for 11 of these (range, one to 18 new indications). No drug has demonstrated safety concerns. Conclusion Nonrandomized clinical trials with definitive end points can yield US Food and Drug Administration approvals, and these drugs have a reassuring record of long-term safety and efficacy.

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Haffner, Marlene E., and John V. Kelsey. "Evaluation of Orphan Products by the U.S. Food and Drug Administration." International Journal of Technology Assessment in Health Care 8, no. 4 (1992): 647–57. http://dx.doi.org/10.1017/s0266462300002348.

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AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

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Rangaraj, Nagarjun, Sunitha Sampathi, Vijayabhaskarreddy Junnuthula, Praveen Kolimi, Preethi Mandati, Sagar Narala, Dinesh Nyavanandi, and Sathish Dyawanapelly. "Fast-Fed Variability: Insights into Drug Delivery, Molecular Manifestations, and Regulatory Aspects." Pharmaceutics 14, no. 9 (August 27, 2022): 1807. http://dx.doi.org/10.3390/pharmaceutics14091807.

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Among various drug administration routes, oral drug delivery is preferred and is considered patient-friendly; hence, most of the marketed drugs are available as conventional tablets or capsules. In such cases, the administration of drugs with or without food has tremendous importance on the bioavailability of the drugs. The presence of food may increase (positive effect) or decrease (negative effect) the bioavailability of the drug. Such a positive or negative effect is undesirable since it makes dosage estimation difficult in several diseases. This may lead to an increased propensity for adverse effects of drugs when a positive food effect is perceived. However, a negative food effect may lead to therapeutic insufficiency for patients suffering from life-threatening disorders. This review emphasizes the causes of food effects, formulation strategies to overcome the fast-fed variability, and the regulatory aspects of drugs with food effects, which may open new avenues for researchers to design products that may help to eliminate fast-fed variability.

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Kharitonovа, L. A., A. M. Zaprudnov, and K. I. Grigoriev. "Mandatory assessment of trophological status and nutrition in children in drugs prescribing." Experimental and Clinical Gastroenterology, no. 1 (May 2, 2020): 4–14. http://dx.doi.org/10.31146/1682-8658-ecg-173-1-4-14.

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The article discusses interactions between medications (Ms) and food. The influence of Ms on the processes of absorption of the essential food ingredients, vitamins, macro- and trace elements in the gastrointestinal tract is analyzed. The significance of the malabsorption syndrome, antibiotic-associated diarrhea as cause of the impaired nutritional status is emphasized. Simultaneously, food products are able of altering the pharmacological effect of some most common drugs. Administration of Ms depending on food intake is discussed. The importance of taking into consideration the influence of foods and theirbiologically active substances on the pharmacokinetics of Ms in the body is pointed out.

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Sharma, Ajitha, and Rathnakar Up. "REVISED FOOD AND DRUG ADMINISTRATION RISK CATEGORIES OF DRUGS DURING PREGNANCY." Asian Journal of Pharmaceutical and Clinical Research 10, no. 7 (July 1, 2017): 77. http://dx.doi.org/10.22159/ajpcr.2017.v10i7.16539.

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Butler, O. D., Woodrow M. Knight, and Jack C. Taylor. "The Regulation of Production Drugs by the Food and Drug Administration." Professional Animal Scientist 2, no. 1 (June 1986): 14–17. http://dx.doi.org/10.15232/s1080-7446(15)32415-3.

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Blankfield, Robert P., and Imran H. Iftikhar. "Food and Drug Administration Regulation of Drugs That Raise Blood Pressure." Journal of Cardiovascular Pharmacology and Therapeutics 20, no. 1 (May 6, 2014): 5–8. http://dx.doi.org/10.1177/1074248414531852.

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Ashley, Donald D. "Clarifying Misconceptions About US Food and Drug Administration Unapproved Drugs Program." Anesthesia & Analgesia 127, no. 6 (December 2018): 1292–94. http://dx.doi.org/10.1213/ane.0000000000003852.

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Dissertations / Theses on the topic "FOOD AND DRUGS ADMINISTRATION"

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Li, Hoi-kwong. "Filing of complaints by the US Food and Drug Administration /." View the Table of Contents & Abstract, 2005. http://sunzi.lib.hku.hk/hkuto/record/B35082471.

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Li, Hoi-kwong, and 李海光. "Filing of complaints by the US Food and Drug Administration." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2005. http://hub.hku.hk/bib/B45010766.

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Lamb, James Alexander. "Under-reporting of Adverse Drug Reactions to the Food & Drug Administration." ScholarWorks, 2018. https://scholarworks.waldenu.edu/dissertations/6055.

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This study examined the potential significant differences in the distribution of adverse drug reactions (ADRs) by reporter (consumer versus physician) and patient outcome at case and event level. This study also contains exploratory questions to evaluate reporting of ADRs by consumers versus physician by system organ class (SOC) and reporter demographics within the United States Food & Drug Administration Adverse Event Reporting System (FAERS). The theoretical foundation applied in this quantitative study was the social amplification of risk framework. Data from the second quarter of 2016 were obtained from FAERS, and a total of 87,807 ADR reports corresponding to 143,399 ADRs were analyzed by utilizing the chi-square test, the odds ratio, and logistic regression. Cross-sectional design was employed to compare reporting of ADRs at the case and event level (case-based and event-based analyses, respectively) between reporters (consumer versus physician), specifically, for patient outcome, as well as SOC and reporter demographics. For both the case-based and event-based analyses, findings revealed that consumers reported more serious ADRs in comparison to physicians. Furthermore, findings confirmed a difference in ADR reporting between consumers and physicians depending on SOC groups. Additionally, consumers reported more nonserious ADRs in comparison to physicians. The results from this study may have implications for positive social change by augmenting pharmacovigilance systems at a national and international level to identify risks and risk factors spontaneously reported after drugs have been on the market.

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Wang, Bo. "Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels." Thesis, Harvard University, 2016. http://nrs.harvard.edu/urn-3:HUL.InstRepos:27007749.

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Background: Genetic biomarkers that predict a drug’s efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but there is concern that there may be insufficient evidence linking use of some biomarkers to clinical benefit. Nevertheless, information about the use of biomarkers appears in the drug label for many prescription medications. This may add confusion to the clinical decision-making process. Objective: To evaluate the evidence supporting pharmacogenomic biomarker testing in drug labels, how frequently testing is recommended, and completeness of citation of the supporting studies. Methods: We used publicly-available databases from the US Food and Drug Administration (FDA) to identify drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (i.e., the ability to predict phenotype) and clinical utility (i.e., the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision-making. Results: Of the 119 drug-biomarker combinations, only 36% (n=43) had labels that provided convincing clinical validity evidence while 15% (n=18) provided convincing evidence for clinical utility. Fifty-one percent of the labels (51%, n=61) made recommendations based on the results of a biomarker test; 30% of these contained convincing clinical utility data. A full description of supporting studies was included in 11% (n=13) of the labels. Discussion: Fewer than one-sixth of drug labels contained or referenced convincing evidence for clinical utility of biomarker testing while over half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data linking testing to patient outcomes does not exist.

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Richert, Lucas. "Pills, politics, and pitfalls : The food and drug administration during the Reagan years." Thesis, University of London, 2010. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.536790.

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Mayhew, Brian Michael. "An evaluation of the food and drug administration’s expedited pathways." reponame:Repositório Institucional do FGV, 2016. http://hdl.handle.net/10438/17995.

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Biopharmaceutical development is characterized by challenging regulations, intense competition and significant costs that result in the need for biopharmaceutical companies to consistently produce innovation biopharmaceutical products. The United States Congress has sought to provide a balanced environment that combines significant regulatory oversight by the US Food and Drug Administration (FDA) with market-based incentives (patent protection, exclusivity) and expedited pathways (accelerated approval, breakthrough designation, fast track designation, and priority review) that seek to quickly identify and move innovative new medicines through development that will address unmet medical need and treat serious or life-threatening diseases or conditions. While FDA’s expedited programs are believed to accelerate the development of innovative drug products, the programs have not been formally measured against their intended purpose: more efficient development and regulatory reviews. This thesis research project attempts to effectively measure FDA’s expedited programs by cataloguing FDA approvals from 1987-2015, measuring development and regulatory review time, and drawing conclusions and making recommendations based on the statistical analyses generated from the project.

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Garmendia, Craig A. "Patterns of Regularity Noncompliance Identified by the U.S. Food and Drug Administration and Their Effects on Meta-analyses." FIU Digital Commons, 2018. https://digitalcommons.fiu.edu/etd/3920.

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The objective of this study was to determine the patterns of regulatory noncompliance, as identified by the U.S. Food and Drug Administration (FDA), and their effects on meta-analyses. In order to achieve these objective, three studies were undertaken: analysis of citations issued by FDA Investigators at the conclusion of an inspection; analysis of regulatory actions taken by the FDA towards clinical researchers based on the observations cited by FDA Investigators; and sensitivity analysis of meta-analyses based on the Agency’s determination of research misconduct, primarily the falsification of data. FDA Investigator citations were analyzed using Chi-Square analysis based on geographic location of the inspection, type of inspection, and type of violation. Temporal changes in the number of inspections and the violations cited were analyzed using bivariate Poisson regression models. Bonferroni correction was employed for temporal changes across the time period analyzed. Regulatory actions taken by the agency were analyzed via Chi-Square or Fisher’s exact test based on changes identified in previous publications, temporal changes, and differences between regulatory action types. Sensitivity analysis of meta-analyses identified through a systematic review were assessed both qualitatively and quantitatively for the effects of including publications of apixaban trials with significant FDA regulatory action, i.e. the comparison of odds ratio point estimate, upper and lower 95% confidence interval, both before and after consideration of falsified data. Under the FDA’s Bioresearch Monitoring program from 2007-2015, the number of inspections increased, but the rate of citation issuance per inspection decreased. One third of the violations were related to adherence to investigational procedures followed by informed consent violations and violations involving study records. During this same time period, 194 clinical researchers received a regulatory action based on FDA’s review of inspection results. Since 2007, rates of significant deviations had decreased. Lack of researcher supervision and submission of false information were cited more frequently for disqualification proceedings. A systematic review found 99 statistical analyses from 22 different meta-analyses available for sensitivity analyses. Nearly one-third resulted in a change in the conclusions reported in the originally published statistical analyses. In approximately the last decade, the number of violations cited during inspections under the Bioresearch Monitoring program has decreased; however, significant improvements can continue to be made regarding adherence to study procedures, the consenting of human subjects, and creation of adequate and accurate study documentation. Disqualification of clinical researchers is more likely to occur when researchers fail to supervise a clinical trial or false information is submitted to the FDA. Falsified data can make its way into the exploding field of meta-analyses, a study method that provides a concise and compelling method for the dissemination of medical intervention knowledge; however, this method can be highly unstable and can provide biased results. A robust sensitivity analysis that considers data quality from available sources can help ensure calculations of the best estimates.

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Balmaceda, Zaira, and Kathy Lin. "Comparison of Findings from Published Weight Loss Trials for Orlistat to the Findings Used by the Food and Drug Administration (FDA)." The University of Arizona, 2010. http://hdl.handle.net/10150/623796.

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Class of 2010 Abstract
OBJECTIVES: The objective was to compare differences in weight loss data presented in published orlistat studies on orlistat to their corresponding studies submitted to the FDA. METHODS: This meta-‐analysis compared one-‐year weight loss data reported in six published orlistat 120 mg studies to data reviewed by the FDA in the New Drug Application (NDA). The primary dependent variables were the percentage of subjects achieving 5% and 10% weight loss. Prior to analysis, weight loss data was stratified into placebo and orlistat groups. Potential for bias was assessed with a funnel plot and by calculating Kendall’s tau. The a priori alpha level was 0.05. RESULTS: Corresponding FDA reviews were located for 6 published orlistat trials. The pooled odds ratio of published vs. FDA 5%weight loss data for the placebo arm was 2.18 (95% CI: 1.83 to 2.60; p < 0.001) and 1.95 (95% CI: 1.70 to 2.24; p < 0.001) for the orlistat arm. The pooled odds ratio of published vs. FDA for 10% weight loss data for the placebo arm was 2.25 (95% CI: 1.74 to 2.91; p < 0.001) and 2.20 (95% CI: 1.88 to 2.57; p < 0.001) for the orlistat arm. The p-‐values for Kendall’s tau for the 5% and 10% weight loss data were 0.054 and 0.34, respectively. CONCLUSIONS: Published orlistat trials presented 5% and 10% weight loss data that were twice of that reported in the FDA-‐reviewed trials, and there was potential for bias in the 5% weight loss data.

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Noh, In Joon. "Essays on Drivers of Quality and Compliance Performance in the Pharmaceutical Industry: Policy, Manufacturing Strategy, and Organizational Learning Perspectives." The Ohio State University, 2020. http://rave.ohiolink.edu/etdc/view?acc_num=osu1595014194719331.

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Barrett, Jane A. "Applying strategles of architectural androgeny to a renovation of and addition to an existing building currently occupied by the food and drug administration." Thesis, Georgia Institute of Technology, 1994. http://hdl.handle.net/1853/23446.

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Books on the topic "FOOD AND DRUGS ADMINISTRATION"

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O'Reilly, James T. Food and drug administration. 2nd ed. [Eagan, MN]: Thomson/West, 2005.

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O'Reilly, James T. Food and drug administration. 2nd ed. [St. Paul, Minn.]: Thomson/West, 2005.

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O'Reilly, James T. Food and drug administration. 2nd ed. Colorado Springs, Colo: Shepard's/McGraw-Hill, 1993.

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The Food and Drug Administration. New York, N.Y: Chelsea House, 1988.

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A, Rettig Richard, Earley Laurence E, Merrill Richard A, and Institute of Medicine (U.S.). Division of Health Sciences Policy., eds. Food and Drug Administration advisory committees. Washington, D.C: National Academy Press, 1992.

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Center for Drug Evaluation and Research (U.S.), ed. Drugs@FDA. Washington D.C: U.S. Food and Drug Administration, Center for Drug and Evaluation Research, 2004.

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Buchta, Teresa M. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.

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United States. Food and Drug Administration. Cincinnati District Office and National Institute for Occupational Safety and Health, eds. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.

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Buchta, Teresa M. Food and Drug Administration, Cincinnati, Ohio. [Atlanta, Ga.?]: U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, 1992.

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Philipson, Tomas J. Is the Food and Drug Administration safe and effective? Cambridge, Mass: National Bureau of Economic Research, 2007.

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Book chapters on the topic "FOOD AND DRUGS ADMINISTRATION"

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Gibbs, Jeffrey N., Iver P. Cooper, and Bruce F. Mackler. "Food and Drug Administration." In Biotechnology & the Environment: International Regulation, 115–24. London: Macmillan Education UK, 1987. http://dx.doi.org/10.1007/978-1-349-09160-7_7.

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Gressner, A. M., and O. A. Gressner. "Food and Drug Administration." In Lexikon der Medizinischen Laboratoriumsdiagnostik, 1. Berlin, Heidelberg: Springer Berlin Heidelberg, 2017. http://dx.doi.org/10.1007/978-3-662-49054-9_1160-1.

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Gressner, A. M., and O. A. Gressner. "Food and Drug Administration." In Springer Reference Medizin, 899. Berlin, Heidelberg: Springer Berlin Heidelberg, 2019. http://dx.doi.org/10.1007/978-3-662-48986-4_1160.

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Nahler, Gerhard. "Food and Drug Administration (FDA)." In Dictionary of Pharmaceutical Medicine, 76. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_574.

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Gooch, Jan W. "Food and Drug Administration (FDA)." In Encyclopedic Dictionary of Polymers, 321. New York, NY: Springer New York, 2011. http://dx.doi.org/10.1007/978-1-4419-6247-8_5212.

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Desanto, Barbara. "US Food and Drug Administration." In The Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 1450–55. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-44556-0_227.

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Pati, Sandipan, and Steve S. Chung. "Approach of the Food and Drug Administration in Development of Antiepileptic Drugs." In Atlas of Epilepsies, 1609–13. London: Springer London, 2010. http://dx.doi.org/10.1007/978-1-84882-128-6_242.

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Weissinger, Judi. "Assessment of Reproductive Toxicology of Drugs at the Food and Drug Administration." In Risk Assessment of Prenatally-Induced Adverse Health Effects, 103–11. Berlin, Heidelberg: Springer Berlin Heidelberg, 1992. http://dx.doi.org/10.1007/978-3-642-77753-0_7.

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Block, Walter E. "The Food and Drug Administration Challenger." In Defending the Undefendable III, 137–39. Singapore: Springer Singapore, 2021. http://dx.doi.org/10.1007/978-981-16-3957-9_38.

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Li, Haodi, Qingcai Chen, Buzhou Tang, Dong Huang, Xiaolong Wang, and Zengjian Liu. "An Initial Ingredient Analysis of Drugs Approved by China Food and Drug Administration." In Communications in Computer and Information Science, 104–9. Singapore: Springer Singapore, 2016. http://dx.doi.org/10.1007/978-981-10-3168-7_10.

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Conference papers on the topic "FOOD AND DRUGS ADMINISTRATION"

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Tapia, J. Carlos, Consolación Molto, Aida Bujosa, Arnoud J. Templeton, Agustí Barnadas, Eithan Amir, and Ariadna Tibau. "Abstract PD10-06: Clinical benefit of breast cancer drugs approved by the United States Food and Drug Administration." In Abstracts: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, Texas. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1538-7445.sabcs19-pd10-06.

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Rose, Charles L. "The food and drug administration (FDA) submission process." In ICALEO® ‘86: Proceedings of the Medicine and Surgery Symposium. Laser Institute of America, 1986. http://dx.doi.org/10.2351/1.5057788.

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Albuquerque, Pedro José Honório de, Laura Guerra Lopes, Jordy Silva de Carvalho, Luzilene Pereira de Lima, and Marina Galdino da Rocha Pitta. "Emerging therapies for amyotrophic lateral sclerosis applied to drug discovery." In XIII Congresso Paulista de Neurologia. Zeppelini Editorial e Comunicação, 2021. http://dx.doi.org/10.5327/1516-3180.021.

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Background: Amyotrophic Lateral Sclerosis (ALS) is a progressive neuromuscular disease mainly caused by genetic disorders. This progressive disorder involves the degeneration of motor neurons at various levels. Drugs have been studied, and they show improvement in survival and reduced progression of the disease, they are riluzole and edaravone. Objectives: Investigate emerging therapies for the treatment of ALS. Methods: The Pubmed database was used to conduct the research, and the keywords were “Amyotrophic Lateral Sclerosis”, “Emerging”, “Therapies”,”Drugs”, all present in Mesh. Articles from 2016 to 2021 were used. And the survey was conducted on May 2, 2021. Results: Only two drugs have been approved yet by the Food and Drug Administration for the treatment of ALS, riluzole and edaravone, and each one offers modest benefits in mortality and/or function. On the other hand, 88 studies of clinical intervention trials are active using different drugs. Current therapies under development include oral tyrosine kinase inhibitors (masitinib, trametinib); the antisense oligonucleotide (tofersen); the human monoclonal antibody inhibitor (ravulizumab); and mesenchymal stem cells (MSC); among others (RT001, Enoxacin, Engensis, ANX005, Deferiprone). Conclusions: Due to gaps in the knowledge of the specific pathophysiology of ALS, the definitive treatment is still a mystery. The drugs currently in use, riluzole and edaravone, are the most promising in terms of delaying the progression of the disease.

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Pera, V., P. Rijnbeek, J. Van Der Lei, J. Kors, R. Parry, E. Van Mulligen, M. De Wilde, G. Brusselle, G. Brusselle, and K. Verhamme. "Characteristics of medication errors among respiratory drugs within the Food and Drug Administration’s Adverse Event Reporting System." In ERS International Congress 2022 abstracts. European Respiratory Society, 2022. http://dx.doi.org/10.1183/13993003.congress-2022.283.

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Etan, Tal, Eitan Amir, Adriana Tibau, Rinat Yerushalmi, Assaf Moore, Daniel Shepshelovich, and Hadar Goldvaser. "Abstract PS14-13: National comprehensive cancer network (NCCN) recommendations for drugs without US food and drug administration (FDA) approval in metastatic breast cancer: A cross-sectional study." In Abstracts: 2020 San Antonio Breast Cancer Virtual Symposium; December 8-11, 2020; San Antonio, Texas. American Association for Cancer Research, 2021. http://dx.doi.org/10.1158/1538-7445.sabcs20-ps14-13.

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Beekman, Jessica, Samantha Popol, Shaun MacMahon, and Steven Peyton. "Analysis of MCPD and Glycidyl Esters: Recent Occurrence Data in U.S. Infant Formulas and Effects of Cooking on Contaminant Concentrations in Frozen Fried Foods." In 2022 AOCS Annual Meeting & Expo. American Oil Chemists' Society (AOCS), 2022. http://dx.doi.org/10.21748/jsat7828.

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Fatty acid esters of 3-monochloro-1,2-propanediol (3-MCPD), 2-monochloro-1,3-propanediol (2-MCPD), and glycidol are process-induced chemical contaminants found in a variety of edible oils and food products containing these oils. Studies have shown these contaminants may be carcinogenic and/or genotoxic, making their presence in foodstuffs a potential health concern. Since 2012, researchers at the U.S. Food and Drug Administration (FDA) have developed methods for the analysis of MCPD and glycidyl esters in a variety of matrices, including edible oils, infant formula, and other processed foods. In addition, these methods have been used to collect occurrence data for 3-MCPD and glycidyl esters in nearly 1000 food samples in an effort to estimate levels of exposure. Since 2021, researchers at the U.S. FDA have analyzed approximately 200 additional infant formula samples purchased in the U.S. in order to update infant exposure estimates. In addition, occurrence studies have been expanded to include the evaluation of 3-MCPD and glycidyl ester levels in processed foods (such as French fries or fried seafood) that require some form of heating or baking prior to consumption. This presentation will detail the results of these recent studies, including an examination of the effects of cooking (such as baking, deep-frying, and air-frying) on contaminant concentrations in frozen fried foods.

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Hudson, B. J. "Exporting medical devices to the USA (how to do business with the Food and Drug Administration)." In IEE Seminar Exporting Medical Devices to the USA: A Practical Guide to the FDA Regulations. IEE, 1998. http://dx.doi.org/10.1049/ic:19980988.

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8

Lueddemann, Tobias, Diqing Chang, Sadik Sahin, and Tim C. Lueth. "Medical device approval process in China since the introduction of the China Food and Drug Administration." In 2016 IEEE Symposium on Product Compliance Engineering (ISPCE). IEEE, 2016. http://dx.doi.org/10.1109/ispce.2016.7492842.

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Sanders, Michael J. "Aseptic Processing and Handling of Citrus Juice." In ASME 1990 Citrus Engineering Conference. American Society of Mechanical Engineers, 1990. http://dx.doi.org/10.1115/cec1990-3606.

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Since the approval of hydrogen peroxide as a package sterilant by the Food and Drug Administration in January 1981, aseptic processing has exploded onto the U.S. marketplace. In fact, during the summer of 1989, an expert panel from the Institute of Food Technologists voted aseptic technology as the food industry’s top innovation of the past 50 years. The major commercial success to date has been the aseptic processing of high acid fruit juices and fruit drinks, particularly when packaged in the 250 ml, single serve, laminated paper box. (Slide 2) Over three billion unit volumes were sold in 1989. This represents greater than a 12% increase over 1988 and means aseptic packaging has captured a larger unit volume than any other food packaging technology has ever done in so short a time. This paper will look at the technologies involved as they relate to citrus juices, the precautions which should be taken to optimize the product, and the promises which the future holds. Paper published with permission.

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Eakin, Cortney, Cheng-I. Liao, Joshua Cohen, Ritu Salani, Daniel Kapp, and John K. Chan. "O013/#813 Trends of metastatic leiomyosarcoma following the us food and drug administration (FDA) warning on laparoscopic power morcellators." In IGCS 2022 Annual Meeting Abstracts. BMJ Publishing Group Ltd, 2022. http://dx.doi.org/10.1136/ijgc-2022-igcs.15.

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Reports on the topic "FOOD AND DRUGS ADMINISTRATION"

1

Philipson, Tomas, and Eric Sun. Is the Food and Drug Administration Safe and Effective? Cambridge, MA: National Bureau of Economic Research, October 2007. http://dx.doi.org/10.3386/w13561.

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2

Blanchard, A. Derived Intervention Levels for Tritium Based on Food and Drug Administration Methodology. Office of Scientific and Technical Information (OSTI), December 1998. http://dx.doi.org/10.2172/4840.

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3

DEPARTMENT OF DEFENSE WASHINGTON DC. Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs. Fort Belvoir, VA: Defense Technical Information Center, February 2008. http://dx.doi.org/10.21236/ada594572.

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4

Blanchard, A. Derived Intervention Levels for Tritium Based on Food and Drug Administration Methodology Using ICRP 56 Dose Coefficients. Office of Scientific and Technical Information (OSTI), June 1999. http://dx.doi.org/10.2172/7962.

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Miller, Patrice, and Alexis Williams. COVID-19’s Impact on Clinical Research. RTI Press, December 2022. http://dx.doi.org/10.3768/rtipress.2022.rb.0032.2212.

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During the COVID-19 pandemic, federal and state restrictions hindered many aspects of clinical trials, such as recruiting patients, which made completing required research tasks difficult or impossible. Many existing guidance documents and policies were redesigned rapidly during the pandemic to accommodate COVID-19-related emergencies. Such policies laid the foundation for change in clinical research. The purpose of this clinical research regulatory review is to determine how regulatory bodies such as the Food and Drug Administration, Office of Human Research Protections, and institutional review boards have responded to challenges in running clinical trials during the COVID-19 pandemic.

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Huang, Jinsheng, Teng Fan, Yuming Rong, Xujia Li, Qi Jiang, Jun Kan, Huijuan Qiu, Qi Quan, Bei Guo, and Guifang Guo. Efficacy of Aidi injection combined with chemotherapy, radiotherapyor chemoradiotherapy for unresectable esophageal cancer treatment: A meta-analysis and systematic review of 29 randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, September 2022. http://dx.doi.org/10.37766/inplasy2022.9.0020.

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Review question / Objective: In recent years, many articles have shown the significant clinical effects of traditional Chinese medicine for esophageal cancer (EC) treatment. These studies involved Chinese medicine injection, decoction, acupuncture, and moxibustion. Chinese medicine injections, including Aidi injection (Aidi) (Z52020236, China food and Drug Administration; composed of 0.15 g/ml cantharis, 5 g/ml ginseng, 10 g/ml Astragalus and 15 g/ml Eleutherococcus senticosus at a ratio of 0.03:1:2:3. The three plant names have been checked with http://www.theplantlist.org 2022/6/4), Shenqifuzheng injection, Kanglaite injection, compound Kushen injection, and Kangai injection, are widely used to treat cancer in clinical practice because of their efficacy and convenience. Aidi combined with standard treatment, including chemotherapy, radiotherapy, or chemoradiotherapy (CR) (Aidi-based combination therapy), showed significant efficacy in the treatment of unresectable EC. However, existing studies are limited to small sample sizes, and the efficacy of Aidi in the treatment of unresectable EC has not been confirmed in large-scale phase III clinical trials. Therefore, it is important to derive more convincing results by analyzing all the reported data. Herein, we conducted a literature search for all randomized controlled trials (RCTs) that applied Aidi-based combination therapy in unresectable EC treatment, and a meta-analysis was performed to evaluate the efficacy of Aidi-based combination therapy in unresectable EC treatment.

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Gupta, Aditya, Tong Wang, Shruthi Ravi, Mesbah Talukder, Jessie Carviel, and Mary Bamimore. Relative efficacy of microneedling in the treatment of pattern hair loss: a protocol for a systematic review with network meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, September 2022. http://dx.doi.org/10.37766/inplasy2022.9.0042.

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Review question / Objective: The objective of the proposed study is to determine the relative efficacy of microneedling and combination of it and other agents for androgenetic alopecia (AGA)—a condition that is also referred to as pattern hair loss. Rationale: Pattern hair loss is one of the most common forms of hair loss in men and women; the condition is associated with decreased quality of life. Oral finasteride and topical minoxidil are treatments currently approved, by the United States Food and Drug Administration, for AGA. However, finasteride has been associated with significant side effects in men, and is not appropriate for women of childbearing potential. Furthermore, topical minoxidil requires daily prolonged use which is time-consuming for patients and requires high compliance to maintain efficacy. Due to these drawbacks, new treatments, such as microneedling, have been investigated. Microneedling involves the creation of small wounds on the scalp that prompt growth factor release and neovascularization—which, in turn, may promote hair growth. Microneedling has been used as a monotherapy—or in combination with other standard therapies—for the treatment of AGA. Further investigation through meta-analysis is salient as this quantitative technique can estimate the relative success of mono- and poly-therapy with microneedling; therefore, findings from a systematic review and meta-analysis on the comparative effectiveness can enable clinicians, patients, and researchers to make more informed decisions.

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Law, Marc, and Gary Libecap. The Determinants of Progressive Era Reform: The Pure Food and Drugs Act of 1906. Cambridge, MA: National Bureau of Economic Research, December 2004. http://dx.doi.org/10.3386/w10984.

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Deng, Jianhao, jiaxing Zhang, QingXia Zhang, and Guowei Zhong. Serotonin syndrome with dextromethorphan alone and in combination with other serotonergic drugs. a systematic review. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, May 2022. http://dx.doi.org/10.37766/inplasy2022.5.0079.

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Review question / Objective: To assess the evidence for serotonin syndrome occurring in the context of dextromethorphan administration. To assess concurrent medication to see if there are associations with 1) other serotonergic medication. Condition being studied: It is uncertain whether use of dextromethorphan alone or in therapeutic doses can cause Serotonin syndrome (SS). Also, SS by dextromethorphan has not previously been systematically reviewed. Therefore, the main aim is to present a systematic review and summary of these studies.

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Bergwerff, A. Residues of veterinary drugs in food : keynote, oral and poster contributions : proceedings of the EuroResidue VIII conference Egmond aan Zee, The Netherlands 23-25 May, 2016. Wageningen: Wageningen UR, 2016. http://dx.doi.org/10.18174/370325.

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